Anlotinib Plus Anti-PD-1 Antibody AK105 for Advanced Pancreatic Cancer

June 18, 2023 updated by: Peking Union Medical College Hospital

Anlotinib Plus Anti-PD-1 Antibody AK105 as Third or More-line Therapy for Advanced Pancreatic Cancer: a Prospective, Single-arm, Open-label, Pilot Study

This study was designed to explore the clinical efficacy of Anlotinib combined with Anti-PD-1 antibody AK105 in the treatment of third- and above -line advanced pancreatic cancer patients, in order to find a better therapy strategy for pancreatic cancer patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

29

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100032
        • Recruiting
        • Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • locally advanced or metastatic pancreatic cancer (PC),
  • histologically or cytologically proven diagnosis of adenocarcinoma or adenosquamous carcinoma,
  • failed to second-line chemotherapy for PC,
  • 18-75 years of age,
  • an Eastern Cooperative Oncology Group performance status score of 0 to 1,
  • adequate organ functions

Exclusion Criteria:

  • had received PD 1 /CTLA 4 antibody treatment
  • had received anti-VEGFR inhibitors or antibodies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Anlotinib plus AK105
Drug: Anlotinib plus AK105
Anlotinib： a multi-kinase inhibitor AK105： an anti-PD-1 antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate (DCR) based on RECIST v. 1 1
Time Frame: 6 weeks
Disease control rate (DCR) based on RECIST v. 1 1 by investigators
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR) based on RECIST V. 1.1
Time Frame: 6 weeks
Objective response rate (ORR) based on RECIST V. 1.1 by investigators
6 weeks
Progression free survival (PFS) measured from the date of anlotinib plus AK105 initiation to the time of progression
Time Frame: 6 weeks
Progression free survival (PFS) measured from the date of anlotinib plus AK105 initiation to the time of progression by investigators assessment
6 weeks
Overall survival (OS) measured from the date of anlotinib plus AK105 initiation to the time of death of any cause
Time Frame: 6 weeks
Overall survival (OS) measured from the date of anlotinib plus AK105 initiation to the time of death of any cause by investigators assessment
6 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 6 weeks
adverse events assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2021

Primary Completion (Estimated)

February 28, 2024

Study Completion (Estimated)

June 29, 2024

Study Registration Dates

First Submitted

February 23, 2021

First Submitted That Met QC Criteria

March 16, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 18, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS2791

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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